MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-03-15 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[16029282]
A doctor had implanted medpor chin implants in two of his patients with an intraoral procedure and that the implants were secured with two mini titanium screws. The doctor indicated that both of the patients developed infections, the first patient five weeks after surgery and the second patient developed an infection three months after surgery. The doctor treated both patient infections with betadin and reported that during the treatment the infection cleared but returned once the treatment was completed. The doctor reported that he had to remove the implants from both patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2006-00004 |
| MDR Report Key | 689121 |
| Report Source | 08 |
| Date Received | 2006-03-15 |
| Date of Report | 2006-03-10 |
| Date Mfgr Received | 2006-02-13 |
| Date Added to Maude | 2006-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal | 30265 |
| Manufacturer Phone | 6784791610 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANT |
| Generic Name | FACIAL RECONSTRUCTION |
| Product Code | JAZ |
| Date Received | 2006-03-15 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 678314 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA 30265 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-03-15 |